(276 days)
The Wedge Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices, such as the SOFIA 6F Catheter, in the neurovasculature.
The Wedge Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The microcatheter has a semi-rigid proximal section with an outer shaft made of Grilamid nylon. The catheter shaft transitions to progressively softer durometers and different lengths of Polyether block amide (Pebax). The distal-most length of the microcatheter, beyond the enlarged segment, consists of a softer, atraumatic polyurethane.
The enlarged segment on the distal end of the Wedge is designed to reduce the gap between the OD of the guidewire and ID of the Sofia 6F. The tapered bulb section, approximately 1 cm length and located approximately 1.5 cm from the distal tip, can be identified on fluoroscopy between the two radiopaque proximal marker bands of the Wedge Microcatheter. The bulb OD (0.068") is sized specifically to work with the lumen ID (0.070") of the Sofia 6F allowing for continuous flush of saline through the Sofia.
Three radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the microcatheter is coated with a hydrophilic polymer coating to reduce friction during navigation in the vasculature. The lubricious inner liner is made from polytetrafluoroethylene (PTFE). A luer fitting on the Microcatheter hub is used for the attachment of accessories. The hub/strain relief provides for the kink resistance at the proximal end. The microcatheter has a straight tip that is designed to be steam shaped by the physicians at the time of the use. A steam shaping mandrel and introducer sheath (accessories) are packaged with the catheter.
The provided document describes the MicroVention, Inc. Wedge Microcatheter and its substantial equivalence to predicate devices, rather than a standalone study with defined acceptance criteria and detailed device performance metrics in the way a clinical trial or a specific performance study for a diagnostic device might.
However, based on the Verification Test Summary and the Biocompatibility Evaluation sections, we can infer the acceptance criteria and reported device performance for various engineering and biological aspects. The "Results" column in these tables implicitly represents the device's performance against an unstated "Pass" acceptance criterion.
Here's an attempt to structure the information as requested, interpreting the "Pass" result as meeting the acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Description | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Verification Test Summary | ||
| Surface Contamination | "Pass" standard | Pass |
| Physical Attributes | "Pass" standard | Pass |
| Force at Break (Catheter Distal Section) | "Pass" standard | Pass |
| Force at Break (Catheter Hub Junction) | "Pass" standard | Pass |
| Freedom from Leakage (Low Pressure, Long Duration) | "Pass" standard | Pass |
| Freedom from Leakage (High Pressure, Short duration) | "Pass" standard | Pass |
| Freedom from Leakage - Air | "Pass" standard | Pass |
| Static Burst Pressure | "Pass" standard | Pass |
| Dynamic Burst Pressure | "Pass" standard | Pass |
| Coating Durability/Lubricity | "Pass" standard | Pass |
| Tip Shape and Tip Retention | "Pass" standard | Pass |
| Simulated Use | "Pass" standard | Pass |
| Flow Rate | "Pass" standard | Pass |
| Kink Resistance | "Reference Only" standard | Reference Only |
| Catheter Stiffness | "Pass" standard | Pass |
| Catheter Flexural Fatigue | "Pass" standard | Pass |
| Catheter Particle Testing | "Pass" standard | Pass |
| Dead Space | "Reference Only" standard | Reference Only |
| Torque Strength | "Pass" standard | Pass |
| Corrosion Resistance* | "Pass" standard | Pass |
| Gauging Test* | "Pass" standard | Pass |
| Separation Force* | "Pass" standard | Pass |
| Unscrewing Torque* | "Pass" standard | Pass |
| Resistance to Overriding* | "Pass" standard | Pass |
| Stress Cracking* | "Pass" standard | Pass |
| Radiopacity* (Visibility under fluoroscopy) | "Pass" standard | Pass |
| Pyrogenicity* | "Pass" standard | Pass |
| Ship Testing* | "Pass" standard | Pass |
| Shelf Life Testing | "Pass" standard | Pass |
| Biocompatibility Evaluation | ||
| Cytotoxicity - Medium Eluate Method | Non-cytotoxic | Non-cytotoxic |
| Sensitization: Maximization Test in Guinea Pigs | Non-sensitizer | Non-sensitizer |
| Intracutaneous Reactivity | Non-irritating | Non-irritating |
| Systemic Injection Test in Mice | Systemically non-toxic | Systemically non-toxic |
| Rabbit Pyrogen Test | Nonpyrogenic (rise |
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).